Senior Regulatory Affairs Associate
IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5–8 years
- Required Skills
- Compliance
Requirements
- 5–8 years of experience in Regulatory Affairs within pharmaceutical, biotech, or life sciences organizations.
- Strong understanding of EU and US regulatory requirements, submission processes, and post-approval obligations.
- Experience in global regulatory submissions and lifecycle management activities.
- Solid knowledge of regulatory documentation standards and compliance frameworks.
- Experience coordinating with cross-functional teams and managing stakeholder communications.
- Strong organizational, planning, and time management skills in a fast-paced environment.
- Educational background in B.Sc., M.Sc., B.Pharmacy, or M.Pharmacy.
- Excellent attention to detail and strong communication skills.
Responsibilities
- Support global regulatory lifecycle management activities across EU, US, and other international markets.
- Contribute to the preparation and execution of regulatory strategies for global and regional submissions.
- Prepare, coordinate, and deliver regulatory submission packages (Modules 1–5) in compliance with applicable requirements.
- Manage post-approval changes, variation submissions, and lifecycle maintenance activities.
- Handle Health Authority queries and ensure timely, accurate responses in collaboration with internal stakeholders.
- Provide submission planning and coordination support, including tracking timelines and deliverables.
- Maintain accurate regulatory documentation and records within Regulatory Information Management (RIM) systems.
- Support safety-related regulatory activities, including aggregate reports and urgent safety updates.
- Assist with audit preparation, compliance activities, and inspection readiness initiatives.
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